MAUDE Adverse Event Report: BARDY DIAGNOSTICS, INC. CAM SYSTEM; HEART MONITORING DEVICE

Model Number	B7000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545); Contact Dermatitis (4546)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) for unit (b)(6) corresponding to complaint reference number (b)(4), has been reviewed for compliance with established device master record (dmr), including certificates of conformance for patient contact materials.Examination of device records determined no discrepancies or instances of non-conformity that could have caused or contributed to the reported event.The cam product instructions for use (ifu) lists skin irritation, allergic skin reactions and allergic symptoms as potential risks associated with device use.The ifu instructs patients to remove the cam immediately and contact their physician if irritation such as redness, severe itching, or allergic symptoms develop.
Event or Problem Description
Original complaint (from (b)(4) (2311)): "cam adhesive caused skin irritation in center of chest which spread to neck area.Skin became itchy, red and burning.Irritation left scar on chest area.Patient stated had to go to urgent care for treatment and was prescribe triamcinolone." additional information: multiple attempts were made to confirm if the prescribed triamcinolone was topical or oral details without success.It is unknown if the patient used a topical or oral prescription.

• Brand Name: CAM SYSTEM
• Common Device Name: HEART MONITORING DEVICE
• Manufacturer (Section D): BARDY DIAGNOSTICS, INC.; 220 120th avenue ne; suite 100; bellevue WA 98005
• Manufacturer (Section G): QUALITEL CORPORATION
• Manufacturer Contact: 220 120th avenue ne; suite 100; bellevue, WA 98005
• MDR Report Key: 25898918
• Report Number: 3014226707-2026-00007
• Device Sequence Number: 5791371
• Product Code: DSH
• UDI-Device Identifier: 40851398007014
• UDI-Public: 40851398007014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: B7000
• Device Lot Number: 192218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Unknown